Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure

Recruiting

• Conditions: Heart Failure; Cardiotoxicity; Pediatric Cancer
• Interventions: Diagnostic Test: Cardiac magnetic resonance imaging (MRI); Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram

• Registration Number: NCT04262830
• Lead Sponsor: Hari Narayan

Brief Summary

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.

Detailed Description

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.

Cardiac remodeling, function, and tissue characteristics will be examined using cardiac MRI in combination with other research assessments to assess the cardiotoxic effects of cancer therapy. Analyses will be performed in a cohort of adolescents and young adults with a history of childhood cancer.

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2028-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• English and Spanish speaking male and female subjects, ages 13-39 years old
• Diagnosis of cancer at age <22 years
• Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior.

Exclusion Criteria

• Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants.
• Medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia.
• Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus).
• Pregnancy (at the time of enrollment).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Study Participants	Echocardiography	This is an observational study where all study participants are within a single group.
All Study Participants	Electrocardiogram	This is an observational study where all study participants are within a single group.
All Study Participants	Cardiac magnetic resonance imaging (MRI)	This is an observational study where all study participants are within a single group.

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (LVEF)	3 - 5 years	LVEF is an assessment of left ventricular global systolic function.

Trial Locations

Locations (1)

Rady Children's Hospital; 🇺🇸 San Diego, California, United States